DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. This action is in response to the amendment filed on 23 June 2026. Applicant's arguments and amendments to the claims have been fully considered but do not place the application in condition for allowance. All rejections not reiterated herein are hereby withdrawn.
In particular, the previous rejection of claim 2 under 35 U.S.C. 112(b) has been obviated by the amendment to the claim.
The previous rejection of claim(s) 1, 2 and 10 under 35 U.S.C. 103 as being unpatentable over Affymetrix. Datasheet. “GeneChip® Human Transcriptome Array 2.0” in view of Lorenz, M. and Ahern, H., as evidenced by the present specification at p. 40, lines 15-23 and p. 42, lines 14-22, has been obviated by the amendment to the claims.
Claim Status
3. Claims 1-10 are pending.
Claims 3-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 2 and 10 have been examined herein.
It is noted that in the reply of 13 February 2025, Applicant elected Group I, drawn to kits, with traverse. As set forth in the restriction requirement of 13 December 2025, where applicant elects claims directed to a product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. Herein, the method claims of Group II do not include all of the limitations of the product claim 1 of Group I. The withdrawn claims of Group II would not be considered for rejoinder with Group I if the claims of Group I become allowable because the withdrawn process claims are not commensurate in scope with an allowable product claim. See MPEP § 821.04.
Non-Compliant Amendment
4. The status identifier used for claim 10 is not correct as this claim was previously presented and is not a new claim. Accordingly, claim 10 should have the status identifier of “(Previously presented)”.
As set forth in MPEP 714 which provides the following list of acceptable alternative status identifiers:
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456
924
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Claim Interpretation
5. The claims as amended recite that the kit comprises “a reagent set consisting of probes and/or primers configured to detect each of the following four biomarkers” and “a label selected from the group consisting of a fluorescent label, a radioisotope label, or an enzymatic label, wherein the label is conjugated directly or indirectly to the probes or primers for detection of the four biomarkers.” The claims have been interpreted as requiring that each primer or probe in the kit (configured to detect each of the four biomarkers) is conjugated directly or indirectly to a fluorescent label, a radioisotope label, or an enzymatic label. That is, the claims do not encompass kits in which one or more of the primers or probes configured to detect the four biomarkers is not conjugated to a fluorescent label, a radioisotope label, or an enzymatic label. Further, the reagent set is considered to consist of only the probes or primers for detecting the biomarkers of NONHSAT006501.2, NONHSAT071649, FAM25A, and CRCT1, wherein the probes or primers are conjugated directly or indirectly to the fluorescent label, radioisotope label, or enzymatic label.
Maintained Claim Rejections - 35 USC § 112(a) - New Matter
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
In the reply of 03 November 2025, the claims were amended to recite that “the kit is configured to achieve a diagnostic performance of at least 0.91 area under the curve (AUC), 71% sensitivity, and 100% specificity.”
The disclosure as originally filed does not provide basis for the broadly claimed kit configured to achieve a diagnostic performance (for the detection of anything) of at least 0.91 area under the curve (AUC), 71% sensitivity, and 100% specificity.
The specification at page 39, lines 13-15 states:
"A panel of four of the eight salivary exRNAs [NONHSAT006501.2; NONHSAT071649; FAM25A; NM_019060] can detect gingivitis with a clinical performance of 0.91 AUC (area under the curve) with 71% sensitivity and 100% specificity."
Similarly, p. 43, lines 6-11 states:
"Linear regression analysis of 8 validated exRNAs revealed that four exRNA marker model [NONHSAT006501.2 (m1), NONHSAT071649 (m2), NM_001146157 (m7), NM_019060 (m10)] could potentially provide a discriminatory performance of 0.91 AUC (area under the curve) with 71% sensitivity and 100% specificity (FIG. 4)."
Thus, the specification provides support only for the concept that the detection assays disclosed therein in which the combination of all 4 of the RNA biomarkers of NONHSAT006501.2 (m1), NONHSAT071649 (m2), FAM25A and CRCT1 were detected in a saliva sample using particular primers or probes provided a diagnostic performance for the detection of gingivitis of 0.91 AUC with 71% sensitivity and 100% specificity.
The specification does not teach the concept of a kit having the recited diagnostic performance (for diagnosing gingivitis or for any other unstated condition). There is no basis in the disclosure for the concept of a kit comprising any probes or primers for the detection of NONHSAT006501.2, NONHSAT071649, FAM25A and CRCT1 conjugated to a fluorescent, radioactive or enzymatic label and instructions, is configured so that the kit itself has the property of being able to achieve a diagnostic performance of at least 0.91 area under the curve (AUC), 71% sensitivity, and 100% specificity.
Response to Remarks:
In the response of 23 June 2026, Applicant states:
“The Examiner rejected Claims 1, 2, and 10 under 35 U.S.C. § 112(a) because the phrase "the kit is configured to achieve a diagnostic performance of at least 0.91 area under the curve (AUC)..." lacked structural description within the specification.
Applicants have deleted this language from the independent claim, rendering this rejection moot”
However, claim 1 was not amended to delete this language. Claim 1, and thereby dependent claims 2 and 10, still recite “wherein the kit is configured to achieve a diagnostic performance of at least 0.91 area under the curve (AUC), 71% sensitivity, and 100% specificity.” The rejection is maintained for the reasons stated above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on 571-272-0731. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682
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